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Participants will be randomized in a 2:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. After Week 48, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments are unblinded, at which point all participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive ATV+COBI+FTC/TDF until COBI tablets become commercially available, or until Gilead Sciences elects to terminate the study.

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the missing = failure method, where participants with missing data were considered to have failed to achieve the endpoint.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Ability to understand and sign a written informed consent form

Plasma HIV-1 RNA levels ≥ 5,000 copies/mL

No prior use of any approved or experimental anti-HIV drug

Normal ECG (or if abnormal, determined by the investigator to be not clinically significant)

Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 30 days following the last dose of study drugs

Age ≥ 18 years

Life expectancy ≥ 1 year

Exclusion Criteria:

New AIDS-defining condition diagnosed within the 30 days prior to screening

Prolonged QTcF (QT interval corrected for heart rate using Fridericia's formula) interval at screening (eg, a prolongation of the QTcF interval of greater than 450 msec for males and greater than 470 msec for females)

PR interval greater than or equal to 200 msec or less than or equal to 120 msec on ECG at screening

QRS greater than or equal to 120 msec on ECG at screening

Implanted defibrillator or pacemaker

Subjects receiving ongoing therapy with any disallowed medications

Current alcohol or substance use judged to potentially interfere with subject study compliance